On May 23, 2022, the Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER) issued a public warning letter to Grimann S.A. de C.V. concerning contradictory information between their product labeling and their electronic drug product listing, causing their firm to violate the Federal Food, Drug, & Cosmetic Act (FD&C Act).
FDA alleged that the firm’s drug product listing was inadequate concerning the corresponding product. Since no action was taken to correct the violations in response to the initial deficiency letter issued on October 18, 2021, the company was later notified of CDER’s intention to remove the drug product’s data from FDA’s Online National Drug Code (NDC) Directory.
In the public warning letter, CDER lists the specific contradictions between the electronic drug listing and the product label. The label image uploaded to the electronic listing file (SPL) did not match the product described in the SPL, nor did it match the product labeled with the corresponding NDC. The active ingredients listed on the product label did not match the SPL, where propylene glycol was incorrectly listed as the product’s only active ingredient. Additionally, the package type and size described under the labeling details section differed from the package type and size described elsewhere in the SPL.
Private label distributors and drug manufacturers are required to provide the FDA with complete, accurate, and up-to-date information concerning their products, which enables FDA to identify counterfeit and fraudulent products and prevent them from reaching the market. The NDC Online Directory is used for insurance reimbursements, electronic medical files, and patient education, underscoring the importance that this data be accurate and thorough.
If your company has received a warning letter for failure to comply with FDA requirements, our team can help you take the steps necessary to come into compliance. Contact our team today for assistance.
This blog/post is provided for informational and educational purposes only and does not constitute legal advice, and is not intended to form an attorney-client relationship. Please contact your regular Benjamin L. England & Associates, LLC attorney contact for additional information.
